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Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial

Study acronym: CARES for Kids
StatusRecruiting
PhasePhase 4
Started2025-01-10
View on ClinicalTrials.gov ↗

Amendment history

2026-03-02
Study Status, Eligibility v3
Start date2024-12-11→2025-01-10
Eligibility criteria+363 characters
Inclusion Criteria: No significant analgesic medication use before surgery as defined in the protocol. For this study, we define significant analgesic medication use before surgery as prescriptions reported by the child or caregiver for 6 days or more of opioid medications in the past 90 days (aligning with American Pediatric Guidelines that were published in September 2024 after the project was fu [...] Undergo one the following: elective tonsil removal (with or without adenoid removal), gallbladd [...]
2025-04-15
Study Status, Contacts/Locations, IPDSharing v2
Study sitesdetails revised at 4 of 4 sites
2025-01-22
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2030-01→2026-10-16
Completion date2030-01→2027-10-31
Start dateestimated 2025-01→confirmed 2024-12-11
Study sitesdetails revised at 4 of 4 sites
2024-10-30
Original filing
This trial is being completed to compare two commonly used options to treat pain after discharge from surgery. Participants that undergo tonsil removal, gallbladder removal, and knee scope will be eligible to enroll. Eligible participants will be randomized to prescription of 1 of 2 groups of medications (Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) plus acetaminophen or low dose opioids with the NSAIDs plus acetaminophen. The key question the study seeks to answer is which option will have the best outcomes and with the fewest side effects?
Trial Details
NCT Number NCT06671002
Lead Sponsor University of Michigan
Collaborators: Patient-Centered Outcomes Research Institute
Conditions Surgery, Pain, Post Operative
Enrollment 900 participants
Start Date 2025-01-10
Primary Completion 2026-10-16 (estimated)
Study Completion 2027-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-04